Anteris Technologies Ltd. and v2vmedtech Inc., have reached concept lock on the first phase of the VClip system.
“This concept lock provides us important proof of concept data. Working closely with engineers and leading interventional cardiologists has allowed us to proceed rapidly as we drive innovation in the TEER space,” v2vmedtech Chief Medical Officer Dr. Vinayak Bapat said.
Anteris is developing DurAVR THV, a new class of transcatheter aortic valve replacement (TAVR) and the world’s only balloon-expandable, single-piece biomimetic aortic replacement valve shaped to mimic the native human valve. v2vmedtech is working on a next-generation transcatheter edge to edge repair (TEER) system for mitral and tricuspid valve regurgitation.
TEER is fast becoming the primary intervention for patients with mitral and tricuspid valve disease but current marketed systems have limitations that often prevent optimal procedural outcomes or limit eligibility for certain patient groups. The VClip is designed to address these unmet needs and provide better outcomes for patients.
“Achieving this milestone is an important step as we advance VClip toward a first-in-human study. Applying the same physician led collaborative design model as we successfully deployed in the development of DurAVR has allowed us to make significant progress in a rapid manner,” v2vmedtech CEO and Anteris Chief Operating Officer David St. Denis stated.
Anteris Technologies Ltd. is a structural heart company that designs, develops, and commercialises medical devices. Founded in Australia, with a significant presence in Minneapolis, Anteris is science-driven, with an experienced team of multidisciplinary professionals delivering transformative solutions to structural heart disease patients. The company’s lead product, DurAVR, is a transcatheter heart valve (THV) for treating aortic stenosis. DurAVR THV was designed in partnership with the world’s leading interventional cardiologists and cardiac surgeons. It is the first transcatheter aortic valve replacement (TAVR) to use a single piece of bioengineered tissue, according to Anteris. This biomimetic valve is uniquely shaped to mimic the performance of a healthy human aortic valve.
DurAVR THV is made using ADAPT tissue, Anteris’ patented anti-calcification tissue technology. ADAPT tissue has been used clinically for more than a decade and distributed for use in over 55,000 patients worldwide. The ComASUR Delivery System was designed to provide controlled deployment and accurate placement of the DurAVR THV with balloon-expandable delivery, allowing precise alignment with the heart’s native commissures to achieve optimal valve positioning.